NCT04365140

Brief Summary

Background. Allergic Contact Dermatitis (ACD) is an inflammatory skin disease mediated by direct contact with allergens as nickel, the most common allergen, that may be related with epigenetic changes. Objective. Evaluate the miR-126 expression and its target VCAM-1, in the skin of patients with ACD to nickel. Methods. Fifteen patients with positive patch test to nickel were included, and the expression of miR-126 and VCAM-1 was evaluated by RT-qPCR.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

8 months

First QC Date

April 23, 2020

Last Update Submit

April 27, 2020

Conditions

Keywords

allergic contact dermatitisnickelmicroRNAsVCAM-1

Outcome Measures

Primary Outcomes (1)

  • Expression of miR-126

    Relative expression of the miR-126 on skin biopsies from ACD patients

    9 months

Study Arms (2)

positive ACD to nickel

Patients with positive epicutaneous patch test to nickel

negative ACD to nickel

Patients with negative epicutaneous patch test to nickel

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female and male patients with allergic contact dermatitis for more than one year

You may qualify if:

  • years of age and older
  • Epicutaneous Patch Test positive to Nickel
  • without previous treatment within the previous 4 weeks

You may not qualify if:

  • Pregnancy
  • nursing
  • menopause
  • consumption of any type of drugs (including anti-inflammatories and hormonal treatments) within the previous 2 months
  • coexistence of other dermatoses conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, 78210, Mexico

Location

Related Publications (3)

  • Martins LE, Reis VM. Immunopathology of allergic contact dermatitis. An Bras Dermatol. 2011 May-Jun;86(3):419-33. doi: 10.1590/s0365-05962011000300001. English, Portuguese.

    PMID: 21738956BACKGROUND
  • Ahlstrom MG, Thyssen JP, Wennervaldt M, Menne T, Johansen JD. Nickel allergy and allergic contact dermatitis: A clinical review of immunology, epidemiology, exposure, and treatment. Contact Dermatitis. 2019 Oct;81(4):227-241. doi: 10.1111/cod.13327. Epub 2019 Jul 9.

    PMID: 31140194BACKGROUND
  • Cerutti C, Edwards LJ, de Vries HE, Sharrack B, Male DK, Romero IA. MiR-126 and miR-126* regulate shear-resistant firm leukocyte adhesion to human brain endothelium. Sci Rep. 2017 Mar 30;7:45284. doi: 10.1038/srep45284.

    PMID: 28358058BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

skin biopsies

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Condition Hierarchy (Ancestors)

Dermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Juan P Castanedo-Cazares, MD

    Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunt professor

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 28, 2020

Study Start

March 1, 2019

Primary Completion

November 1, 2019

Study Completion

November 30, 2019

Last Updated

April 29, 2020

Record last verified: 2020-04

Locations